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NCT02546531 · ClinicalTrials.gov registry record · Phase 1
Defactinib Combined With Pembrolizumab and Gemcitabine in Patients With Advanced Cancer
A Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT02546531 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 43 participants.
The verdict
NCT02546531, a Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
In pancreatic cancer, targeting the tumor microenvironment has become a promising therapeutic strategy. Focal adhesion kinase (FAK) pathway activation is essential for promoting a fibrotic and inflammatory tumor microenvironment, and FAK inhibitors have demonstrated reasonable anti-tumor activity in the preclinical setting. Furthermore, a maximal synergetic effect was achieved when a FAK inhibitor was given in combination with a PD-1 antagonist and chemotherapy in multiple pancreas tumor animal models. This supports the concept of using FAK inhibitors to reduce stromal fibrosis during checkpoint immunotherapeutic treatment. Therefore, these robust preclinical findings will be tested in the proposed phase I trial.
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Gemcitabine
- BIOLOGICAL Defactinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2016-02-03 |
| Est. Completion | 2021-01-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02546531
The ClinicalTrials.gov registry entry for NCT02546531 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT02546531 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02546531 about?
NCT02546531 is a clinical study titled "Defactinib Combined With Pembrolizumab and Gemcitabine in Patients With Advanced Cancer". In pancreatic cancer, targeting the tumor microenvironment has become a promising therapeutic strategy. Focal adhesion kinase (FAK) pathway activation is essential for promoting a fibrotic and inflammatory tumor microenvironment, and FAK inhibitors have demonstrated reasonable anti-tumor activity in...
What is the current status of trial NCT02546531?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2016-02-03. Estimated completion is 2021-01-11.
What interventions are being tested in trial NCT02546531?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Gemcitabine (DRUG), Defactinib (BIOLOGICAL).
Who is sponsoring clinical trial NCT02546531?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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